Supplier Quality Engineer

We are seeking a Supplier Quality Engineer with 5–8 years of experience to support active FDA

remediation efforts following a Warning Letter. This role will focus on supplier risk classification,

control enhancement, and alignment between DFMEAs, PFMEAs, and supplier manufacturing processes.

Due to multiple company acquisitions, legacy DFMEAs and supplier controls are not consistently aligned with current risk levels. This position will work directly with suppliers to strengthen controls for medium-to-high risk failure modes and support remediation activities while temporarily

• Classify supplier risk based on severity, occurrence, and detection, with a focus on medium to high severity risks, including zero-tolerance occurrence, implement enhanced supplier controls, and evaluate supplier process capability and inspection effectiveness.
• Review DFMEAs and PFMEAs to assess alignment with supplier processes, identify gaps resulting from legacy systems following acquisitions, and recommend risk rating adjustments based on actual supplier performance and controls.
• Support or execute IQ/OQ/PQ activities for supplier processes.
• Support troubleshooting related to supplier nonconformances.
• Serve as a technical representative to suppliers.

• FDA inspections or Warning Letter remediation.
• CAPA investigations and root cause analysis.